The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

Device Description

The Genesis Implant System includes implants, and associated surgical, restorative and dental laboratory components. Genesis implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement tooth root, which provides a stable foundation for restorations. Genesis implants are manufactured from Grade 4 titanium, have a tapered or straight cylindrical design with an internal indexing connection, and are available in various platform diameters and lengths. The implants have a macro-, micro- and nano-topography and are treated with the BioSpark process, which results in a hydrophilic surface enriched with calcium and phosphorous ions. The implant collar is micro-roughened and treated with the AnaTite" process, which results in a pink color for enhanced esthetics. The majority of Genesis abutments are manufactured from Grade 5 titanium and are treated with the AnaTite process. Other Genesis abutments are made from Grade 5 titanium/plastic or gold alloy/plastic. Abutments intended for fixed restorations utilize a Grade 5 titanium screw for attachment to the implant. Genesis abutments and associated restorative components are manufactured in a variety of sizes and configurations to be compatible with the implant platforms.

AI/ML Overview

The provided text is a 510(k) summary for the Genesis Implant System, a dental device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. This type of submission generally doesn't include the same kind of detailed acceptance criteria and clinical study results that an AI/software as a medical device (SaMD) would. Therefore, much of the requested information regarding AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table as would be expected for a SaMD that relies on specific performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices through a combination of material properties, design characteristics, and non-clinical testing confirming those characteristics are maintained or improved.

The device performance is reported in qualitative terms, demonstrating properties consistent with or superior to predicate devices.

Feature / Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Materials	Biocompatible materials used in predicate devices (Grade 4 & 5 titanium, gold alloy, plastic)	Genesis implants are manufactured from Grade 4 titanium. Genesis abutments from Grade 5 titanium, Grade 5 titanium/plastic, or gold alloy/plastic. All are biocompatible materials used in predicate devices.
Design	Similar design (threaded, rootform implants, internal indexing connection, various sizes/configurations)	Genesis implants have a tapered or straight cylindrical design with an internal indexing connection, available in various platform diameters and lengths. Genesis abutments are in a variety of sizes and configurations compatible with implant platforms. Explicitly states "Genesis implants are similar in design and materials to the predicates in that all are threaded, rootform implants." and "The Genesis system has the same implant/abutment TiLobe™ internal connection as the PrimaConnex system."
Mechanical Properties (Fatigue Testing)	Consistent with ISO 14801 and FDA Special Controls Guidance for root-form endosseous dental implants and abutments.	Genesis implants with angled abutments were fatigue tested in accordance with ISO 14801 and FDA's Special Controls Guidance. (No specific numerical results are provided in this summary, but the implicit acceptance is that they passed).
Insertion Torque / Primary Stability	Optimized insertion torque to limit pressure on bone while ensuring good primary stability.	In a bench study using simulated bone material, moderate insertion torque was shown when Genesis implants were placed utilizing appropriate surgical instrumentation.
Surface Treatment (AnaTite - Coloration)	Produces a pink color resembling natural gingival tissue for enhanced esthetics.	An in vivo study has shown that pink coloration (from AnaTite treatment) most closely resembles natural gingival tissue. The color is produced by anodization, a common process. This aligns with or improves upon aesthetic characteristics.
Surface Treatment (BioSpark - Osseointegration)	Promote osseointegration, hydrophilic surface, enriched with calcium and phosphorus ions, nano-rough topography.	Genesis implants have a macro-, micro-, and nano-topography and are treated with the BioSpark process, resulting in a hydrophilic surface enriched with calcium and phosphorous ions. Contact angle testing confirmed hydrophilicity. Energy dispersive spectroscopy and sputter mass spectroscopy confirmed presence of calcium and phosphorus ions. Scanning electron microscopy demonstrated surface roughness at macro-, micro-, and nano-levels. Mineralization potential reported in published literature.
BioSpark Biological Efficacy (Osseointegration Speed)	Facilitate faster osseointegration.	Demonstrated by significant bone-to-implant-contact (BIC) in the cortical bone of sheep at 4 weeks compared to machined or blasted titanium. In vitro studies showed: significant increase in cellular metabolic activity (1-7 days), significant increase in osteoblast proliferation (1-3 days), and early fibronectin absorption and enhanced adhesion, proliferation, and differentiation of osteoblasts (24, 48, 72 hours) on BioSpark treated cp-Ti disks compared to controls. Note: Results in animal studies are not necessarily predictive of human clinical results.

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical testing (bench studies, in vitro studies, animal studies). There is no "test set" in the context of human data or AI model evaluation.

Fatigue Testing: Conducted in accordance with ISO 14801 and FDA Special Controls Guidance. The number of implants/abutments tested is not specified.
Insertion Torque Bench Study: Used "simulated bone material." The sample size is not specified.
AnaTite In Vivo Study (Coloration): "An in vivo study has shown..." No details on sample size or species.
BioSpark Animal Study (Osseointegration): "significant bone-to-implant-contact (BIC) in the cortical bone of sheep at 4 weeks." Sample size not specified.
BioSpark In Vitro Studies: These involved "cp-Ti disks" (commercially pure titanium disks). Sample sizes for these experiments are not specified.

Data Provenance:

Bench studies (fatigue, insertion torque)
In vitro studies (cellular metabolic activity, osteoblast proliferation, fibronectin absorption, adhesion, proliferation, differentiation)
Animal studies (sheep for BIC, unspecified animal for AnaTite coloration)
Published literature (for mineralization potential)

All these are non-clinical, controlled experiments. No human data (retrospective or prospective) is mentioned for the performance evaluation of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This is not an AI/SaMD submission evaluating human data against expert ground truth. The "ground truth" for the non-clinical tests is based on objective measurements and established scientific methods (e.g., ISO standards, microscopy, spectroscopy, biological assays, bone-to-implant contact measurements).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there is no human-annotated test set requiring adjudication in this context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/SaMD. There are no "human readers" or "AI assistance" relevant to an MRMC study described in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluations relies on:

Physical measurements and material science: e.g., chemical composition (energy dispersive spectroscopy, sputter mass spectroscopy), surface topography (scanning electron microscopy), wettability (contact angle testing), mechanical strength (fatigue testing per ISO 14801).
Biological assays in vitro: measuring cellular metabolic activity, osteoblast proliferation, fibronectin absorption, adhesion, and differentiation.
Histomorphometry in animal models: bone-to-implant contact (BIC) in sheep.
Visual assessment (in vivo): comparing pink coloration to natural gingival tissue.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/SaMD. There is no concept of a "training set" for physical device testing. The "learning" for the device design would come from long-standing scientific and engineering principles in dental implantology, feedback from predicate devices, and internal R&D.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set in the AI sense. The design and material choices are informed by existing scientific knowledge, performance of predicate devices, and internal research and development validated by the non-clinical tests described.

Summary

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510(k) Summary

OCT 2 8 2010

Administrative Information

Manufacturer Name:	Keystone Dental, Inc.144 Middlesex TurnpikeBurlington, MA 01803Telephone: (781) 328-3300Fax: (781) 328-3400
Official Contact:	John A. Capone, RAC
Date Prepared:	October 27, 2010
Device Name and Classification
Trade/Proprietary Name:	Genesis Implant System
Common Name:	Dental Implants and Abutments
Classification Information:	Endosseous Dental Implant(21 CFR 872.3640), Class IIEndosseous Dental Implant Abutment(21 CFR 872.3630), Class II
Product Codes	DZE, NHA

Device Classification Panel

The Classification Panel for these devices is the Dental Products Panel. Premarket Notifications are reviewed by FDA's Dental Devices Branch.

Device Name	Manufacturer	510(k) Number(s)
PrimaConnexTM Internal Connection Implant System	Keystone Dental	K051614
Straumann® Dental Implant System	Straumann	K053088, K061176
NanoTiteTM Dental Implants	Biomet 3i	K062432
TiUnite® NobelActiveTM Implants	Nobel Biocare	K050705, K071370

Legally Marketed Devices to Which Equivalence is Claimed (Predicate Devices)

Device Description

Genesis implants are manufactured from Grade 4 titanium, have a tapered or straight cylindrical design with an internal indexing connection, and are available in various platform diameters and lengths (see table below).

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Implant Type	Implant Diameter	Implant Lengths
Straight Implant	3.8mm	8.5, 10, 11.5, 13, 14.5, 16 & 18mm
	4.5mm	8.5, 10, 11.5, 13, 14.5, 16 & 18mm
Tapered Implant	3.8mm	8.5, 10, 11.5, 13, 14.5, 16 & 18mm
	4.5mm	8.5, 10, 11.5, 13, 14.5, 16 & 18mm
	5.5mm	8.5, 10, 11.5, 13, 14.5 & 16mm
	6.5mm	8.5, 10, 11.5 & 13mm

The implants have a macro-, micro- and nano-topography and are treated with the BioSpark process, which results in a hydrophilic surface enriched with calcium and phosphorous ions. The implant collar is micro-roughened and treated with the AnaTite" process, which results in a pink color for enhanced esthetics.

The majority of Genesis abutments are manufactured from Grade 5 titanium and are treated with the AnaTite process. Other Genesis abutments are made from Grade 5 titanium/plastic or gold alloy/plastic. Abutments intended for fixed restorations utilize a Grade 5 titanium screw for attachment to the implant. Genesis abutments and associated restorative components are manufactured in a variety of sizes and configurations to be compatible with the implant platforms (see table below).

Abutment Type	Abutment Material	Abutment Angulations
Healing Abutment	Grade 5 titanium	N/A
Temporary Abutment	Plastic (PMMA)	N/A
Ti Temporary Abutment	Grade 5 titanium	N/A
Esthetic Contour Ti Abutment	Grade 5 titanium	Straight and 15°
UCLA Gold/Plastic Sleeve	Gold Alloy/ Plastic (POM)	N/A
SureConnect Abutment	Grade 5 titanium	N/A
Locator Abutment	Grade 5 titanium	N/A
Snap Abutment	Grade 5 titanium	N/A

Indications for Use

Summary of Technological Characteristics

Predicate devices for the Genesis Implant System were selected based on similar intended use and technological characteristics. All devices are intended for replacing missing teeth and supporting single or multiple-unit restorations in the mandible and/or maxilla. Genesis implants are similar in design and materials to the predicates in that all are threaded, rootform implants.

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510(k) Premarket Notification

Genesis, SLActive and TiUnite implants are all constructed of biocompatible Grade 4 titanium and are sterilized using gamma radiation. Genesis implants are macro- and microroughened as are PrimaConnex, SLActive and TiUnite implants. Genesis implants are further treated with the BioSpark process, which results in a nano-rough topography. NanoTite implants are similar in this regard, as they also feature a nano-rough surface. In addition to the nano-topography, the BioSpark process produces a hydrophilic surface. These surface characteristics are also found on SLActive implants. The BioSpark surface incorporates calcium and phosphorus ions to create an enriched surface, a characteristic shared by NanoTite and TiUnite implants.

Genesis abutments are made from biocompatible materials used in the predicate PrimaConnex, SLActive, NanoTite and TiUnite abutments, including Grade 5 titanium, gold alloy and plastic. The Genesis system has the same implant/abutment TiLobe" internal connection as the PrimaConnex system. Genesis titanium alloy abutments and implant collars receive the AnaTite surface treatment, which produces a pink-colored surface intended to resemble the appearance of gingival tissue. The color is produced by anodization, a common process for treating titanium, which is also used for components of the Straumann and PrimaConnex implant systems.

Summary of Non-Clinical Testing

The performance of the Genesis Implant System has been demonstrated through non-clinical testing and published literature. The following is a summary of the relevant in vivo and in vitro studies and bench testing.

Genesis implants with angled abutments were fatigue tested in accordance with ISO 14801 and the FDA's Special Controls Guidance on root-form endosseous dental implants and abutments. Genesis instruments, implant threads, and implantation procedures have been designed to optimize insertion torque in order to limit the pressure applied to bone while ensuring good primary stability. In a bench study using simulated bone material, moderate insertion torque was shown when Genesis implants were placed utilizing appropriate surgical instrumentation.

The AnaTite treatment produces a pink coloration on the surface of the Genesis implant collar and abutments. An in vivo study has shown that pink coloration most closely resembles natural gingival tissue.

The BioSpark treatment produces chemical and physical implant surface characteristics that promote osseointegration. These characteristics have been evaluated by various methods. Contact angle (wettability) testing has shown the Genesis implant surface to be hydrophilic. Energy dispersive spectroscopy and sputter mass spectroscopy have confirmed the presence of calcium and phosphorus ions on BioSpark treated surfaces. Mineralization potential of the BioSpark surface has been reported in published literature. Surface roughness at the macro-, micro-, and nano-level has been demonstrated through scanning electron microscopy. These combined characteristics of the BioSpark surface facilitate faster osseointegration, as demonstrated by significant bone-to-implant-contact (BIC) in the cortical bone of sheep at 4 weeks compared to machined or blasted titanium, and as demonstrated by in vitro studies, which vielded the following individual results:

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Significant increase in cellular metabolic activity over 1 to 7 days in simulated body . fluid on cp-Ti disks treated with BioSpark when compared to machined titanium
. Significant increase in osteoblast proliferation over 1 to 3 days on cp-Ti disks treated with BioSpark when compared to machined or acid etched titanium
Early fibronectin absorption and enhanced adhesion, proliferation, and differentiation . of osteoblasts at 24, 48 and 72 hours on cp-Ti disks treated with BioSpark when compared to other anodic spark deposition (ASD) surfaces

Results in animal studies are not necessarily predictive of human clinical results.

Conclusion

The Genesis Implant System utilizes the same materials and exhibits similar mechanical properties and surface characteristics as the predicate implant systems. The information provided in this 510(k) premarket notification supports the claim of substantial equivalence.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. John A. Capone Director, Regulatory Affairs and Quality Assurance Keystone Dental, Inc. 144 Middlesex Turnpike Burlington, Massachusetts 01803

OCT 2 8 2010

Re: K101545

Trade/Device Name: Genesis Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 22, 2010 Received: October 25, 2010

Dear Mr. Capone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a preemarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Capone

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K101545

Device Name: Genesis Implant System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Susan Kumer

Concurrence of CDRH, Office of Deflivision Bignom (f(ODE)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Numbe

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.